title: Prospective comparison of Abbott RealTime HBV DNA and Versant HBV DNA 3.0 assays for hepatitis B DNA quantitation: impact on HBV genotype monitoring.
abstract: The quantitation of human hepatitis B virus (HBV) in the serum of infected patients is recommended to characterize the course of chronic HBV infection. The aim of this prospective study was to evaluate the performance of the Abbott RealTime PCR assay for HBV DNA quantitation by comparison with the standard Versant HBV DNA 3.0 assay. The better sensitivity and broader dynamic range of HBV DNA quantitation using the Abbott RealTime PCR assay was confirmed by the study of 362 serum samples from 311 patients. In addition, data analysis revealed the concordance of HBV DNA quantitations between the two assays. When this evaluation was assessed as a function of HBV genotype, there was discordance for HBV genotype C samples. Thus, we performed an in-house PCR to confirm the discrepancy observed regarding the HBV genotypes. The in-house PCR results agreed better with the Abbott RealTime PCR method when compared with the standard hybridization assay. In conclusion, the wide dynamic range of HBV DNA quantitation achieved with the Abbott RealTime PCR assay makes it appropriate for the clinical monitoring of HBV infected patients. However, a change of HBV DNA quantitation method could influence results on the follow-up of HBV genotype C infected patients.
authors.affiliation: Inserm, U845, Pathogenèse des Hépatites Virales B et Immunothérapie, Paris, France.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Pol
authors.forename: Catherine
authors.initials: C
authors.lastname: Le Pendeven
authors.forename: Agnes
authors.initials: A
authors.lastname: Beby-Defaux
authors.forename: Elodie
authors.initials: E
authors.lastname: Rabut
authors.forename: Jean Philippe
authors.initials: JP
authors.lastname: Jais
authors.forename: Marilyse
authors.initials: M
authors.lastname: Pilloux
authors.forename: Catherine
authors.initials: C
authors.lastname: Osada
authors.forename: Fadila
authors.initials: F
authors.lastname: Zatla
authors.forename: Hichem
authors.initials: H
authors.lastname: Assami
authors.forename: Jean Didier
authors.initials: JD
authors.lastname: Grange
authors.forename: Dina
authors.initials: D
authors.lastname: Kremsdorf
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Nicolas
authors.forename: Patrick
authors.initials: P
authors.lastname: Soussan
mesh_terms: D004279:DNA, Viral / Q000097:blood* / Q000235:genetics*; D005838:Genotype; D006515:Hepatitis B virus / Q000145:classification* / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000821:virology*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D004279:DNA, Viral